Polyethylene Glycol Safety in Children

Status Recruiting

Clinical Trial Summary

The primary objective is to measure levels of selected PEG 3350 components and metabolites in the blood and urine of children who are already taking PEG 3350 compared to children who are not taking PEG 3350. Changes to medical therapy are not recommended as part of this study.

Clinical Trial Description

For subjects taking PEG 3350, blood and urine will be collected 1.5 to 4 hours after subjects take PEG 3350. For subjects who are not taking PEG 3350, the same PEG 3350 components and metabolites will be measured in blood and urine. PEG 3350 containing medicines from study subjects will be analyzed for the same PEG 3350 components and metabolites. A stool specimen will be collected for future studies. Additional data will be obtained from: - Review of medical records. - A brief questionnaire. - Child Behavior Checklist (CBCL) from the Achenbach System of Empirically Based Assessment (for children more than 1.5 years old) - Bayley-IV Social-Emotional Scale assessment (for children less than 1.5 years old) ;

Study Design

Related Conditions & MeSH terms

Children, Only

Clinical Trial Details

NCT number	NCT05424757
Study type	Observational [Patient Registry]
Source	Children's Hospital of Philadelphia
Contact	Amanda DeGunia, MA
Phone	215-590-2603
Email	deguniaa@chop.edu
Status	Recruiting
Phase
Start date	September 30, 2022
Completion date	June 2024

View Details

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